Clinical Research Coordinator (Central NJ)

| Greater NYC Area | Hybrid
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Background

Today, the biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $100M+. And the problem is only getting worse.

At TrialSpark, we don’t believe it has to be this way. Through technology and a new operational model, we’re reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster. 

We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, and staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care. And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.

Job Description

As a Clinical Research Coordinator, you will be responsible for the core of what TrialSpark delivers – efficient and high quality clinical trial operations. You will work closely with Principal Investigators (PIs) in the TrialSpark network, Trial Operations colleagues and cross-functional colleagues across the TrialSpark organization to conduct clinical trials across the broader NYC metropolitan area. You also will be expected to seek, identify and execute on opportunities to improve Trial Operations and the broader organization.

Key responsibilities will include:

  • Leading study start-up and initiation across TrialSpark trial sites.
  • Reviewing and attaining fluency in study protocols.
  • Contributing to the development of and executing on strategies to identify and reach patients potentially eligible for relevant studies across TrialSpark trial sites.
  • Facilitating the patient informed consent process.
  • Conducting patient screening, baseline, treatment, follow-up and other necessary study-related visits.
  • Receiving, storing, accounting for and monitoring Investigational Product (IP).
  • Maintaining thorough understanding of safety reporting guidelines and monitoring for and reporting Adverse Events (AEs) and Serious Adverse Events.
  • Collecting, transporting, processing and shipping biological samples, ensuring all appropriate tests, procedures and laboratory tests are completed.
  • Collecting, handling and storing study data, including source documents, Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
  • Ensuring trial site regulatory binders are maintained throughout the lifecycle of studies
  • Clarifying and resolving data queries in source documents and CRFs.
  • Proactively communicating with and facilitating collaboration among sponsors, PIs, patients, monitors, IRBs, vendors and other key stakeholders throughout studies.
  • Assisting with setting up trial sites at the start of studies and with closing out trial sites at the end of studies, and maintaining trial sites.
  • Responding to requests for information and access from inspectors and/or auditors
  • Contributing to the mapping and building of study-specific eSource.
  • Supporting other CRCs, including conducting quality control checks of their work and providing coaching / feedback to enable professional development.
  • Contributing to the development of new processes, procedures, tools and training to enhance clinical research activities across TrialSpark.
  • Serving in an advisory capacity for cross-functional teams working on initiatives to improve the broader organization.

Ideal Candidate Profile

  • You have at least 1 year of experience as a CRC running industry-sponsored clinical trials.
  • You have experience performing phlebotomy, collecting vital signs and performing ECGs.
  • You are a certified rater and/or have fluency in EDC systems.
  • You have Advanced Cardiac Life Support (ACLS) or Basic Life Support (BLS) certification.
  • You have Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA) CRC Certification.
  • You possess a deep understanding of site-level quality and Good Clinical Practice Guidelines (GCP) guidelines.
  • You are highly process- and detail-oriented.
  • You are comfortable operating in a fast-paced environment with a high degree of ambiguity.
  • You are proactive, strategic, implementation-focused and ready to roll up your sleeves and make an impact right away.
  • You excel in partnering cross-functionally and are known for being someone that people across the company love to work with.
  • You are low ego, collaborative, and a fast-learner.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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Technology we use

  • Engineering
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Location

Our office is located in Manhattan, near the Empire State Building. The area is lively and has great food and transportation options!

An Insider's view of Formation Bio

What’s the vibe like in the office?

The space is very open which makes it easy to collaborate and engage with different teams across the organization. People are very welcoming, supportive, and friendly. There is always a variety of different food and drinks available in the kitchen, in addition to foods that co-workers bring in for everyone to taste!

Joseph Frappaolo

IT Support Technician

What projects are you most excited about?

The project that excites me most is our new hire onboarding program because of the impact it will have on our company. Though we have a robust onboarding program in place already, we have the opportunity to think creatively about how to make the experience even better for our new hires, from the moment they accept our offer.

Erin Siegel

Senior People Operations Manager

How has your career grown since starting at the company?

I started working at Formation Bio in July of 2018. I joined the company as a Clinical Research Coordinator and was allowed to grow and adapt into new roles as the company's business model shifted. I transitioned into working as a Clinical Trial Associate after a couple of years, and now have over a year of experience as a Clinical Project Manager!

Gurpreet Singh

Clinical Project Manager

How has your career grown since starting at the company?

Formation Bio has given me the opportunity to take ownership over big projects and work streams, allowing me to have an impact on key functional business areas.

Maya Dongier

Senior Accounting Manager

What are Formation Bio Perks + Benefits

Formation Bio Benefits Overview

Formation Bio is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Culture
Open door policy
Open office floor plan
Employee resource groups
Hybrid work model
Flexible work schedule
Diversity
Mandated unconscious bias training
Diversity employee resource groups
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental insurance
Vision insurance
Health insurance
Life insurance
Financial & Retirement
401(K)
Company equity
Pay transparency
Child Care & Parental Leave Benefits
Generous parental leave
Vacation & Time Off Benefits
Unlimited vacation policy
Paid holidays
Paid sick days
Office Perks
Company-sponsored outings
Yearly retreat and holiday party, regular team events and outings!
Free snacks and drinks
Company-sponsored happy hours
Fitness stipend
Home-office stipend for remote employees
Mother's room
Professional Development Benefits
Job training & conferences
Lunch and learns
Promote from within
Continuing education stipend
Virtual coaching services

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